Food and Drug Administration

In Brief: US Legislators Put Medical Device Tax Back on Ice

US lawmakers have delayed reestablishing the Medical Device Excise Tax (MDET) by another two years as part of a short-term government funding arrangement.

US FDA Delays Contentious Medical Device Intended Use Rule

EMERGO SUMMARY OF KEY POINTS:

  • US FDA has indefinitely delayed new requirements for evidence used to determine intended use.
  • The intended use-related requirements are part of a larger final rule covering tobacco products that fall under US medical device regulations.
  • The other parts of the final rule will go into effect in March 2018.

FDA Formalizes UDI Compliance Deadline Extension for Low-risk Devices

EMERGO SUMMARY OF KEY POINTS:

  • US FDA has published guidance setting new UDI compliance deadlines for some Class I and unclassified medical devices.
  • The new deadlines were initially proposed in summer 2017.

US Regulators Refine Least Burdensome Provisions for Medical Device Oversight

EMERGO SUMMARY OF KEY POINTS:

  • US FDA has updated guidance on how least burdensome provisions are applied to medical device registration and oversight.
  • The new guidance applies across all aspects of FDA medical device regulation.
  • The FDA’s least burdensome approach may lead to less onerous US market authorization requirements for some manufacturers.

Final Guidance from US FDA on Clinical Evaluation of Software as a Medical Device (SaMD)

EMERGO SUMMARY OF KEY POINTS:

  • US FDA final guidance on clinical evaluation of software as a medical device (SaMD) is now published.
  • The guidance utilizes SaMD clinical evaluation principles and recommendations issued by the International Medical Device Regulators Forum (IMDRF).
  • US regulators intend to use this guidance as a basis for developing more specific SaMD clinical evaluation guidance in the future.

US Regulators Lay Out Medical Device, IVD Guidance Priorities for 2018

EMERGO SUMMARY OF KEY POINTS:

  • The US FDA’s Center for Devices and Radiological Health (CDRH) unit has publicized plans for medical device and IVD guidances over the next year.
  • High-priority areas of focus for CDRH in 2018 include 510(k) third-party reviews and abbreviated pathways, Unique Device Identification (UDI) deadlines for low-risk devices and device accessory classification.
  • Not all planned CDRH guidance documents will be published due to resource allocation and other regulatory obligations.

US FDA Rolls Out Trio of Digital Health and Medical Software Guidances

EMERGO SUMMARY OF KEY POINTS:

  • US FDA has issued three new guidances focused on digital health technology regulations.
  • The guidances stem from 21st Century Cures Act requirements for timelier registration processes for digital medical technologies.

Encryption, FIPS 140 and Medical Devices: Frequently Asked Questions

EMERGO SUMMARY OF KEY POINTS:

  • Pressure from US regulators and healthcare purchasing organizations for medical devices to demonstrate adequate encryption capabilities is increasing.
  • Compliance with the Federal Information Publications Standard (FIPS) 140-2 standard enables manufacturers to demonstrate adequate encryption tools for their devices.
  • FIPS 140-2 compliance is best addressed early in the medical device design phase.

Final FDA Guidance on When Medical Device Changes Require New 510(k) Submissions

EMERGO SUMMARY OF KEY POINTS:

  • US FDA has issued final guidance documents for changes to medical device hardware and software that require new 510(k) applications.
  • The final guidances do not differ substantially from draft versions published in 2016.

MDUFA IV: US FDA Sets Performance Goals for De Novo Medical Device Reviews

EMERGO SUMMARY OF KEY POINTS:

  • US FDA has published performance goals for handling de novo medical device submissions.
  • De novo user fees and performance goals were established under the Medical Device User Fee Amendments of 2017 (MDUFA IV).
  • FDA has set a 150-day timeframe for review of de novo applications.

Pages